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Questions & answers

On this page we try to answer questions about the IVDR with relevance for diagnostic laboratories/health institutions. Questions can be submitted to We will do our best to answer the questions that we receive on this page of the ESLHO website.

The information on this page was composed using our best knowledge. If you notice that any information is outdated, inaccurate or incorrect, please let us know.


What is the IVDR?
What are in vitro diagnostic medical devices (IVDs)?
Why was a new regulation on IVDs needed?
What are the consequences of the IVDR for diagnostic laboratories?
What are the consequences of the IVDR for IVD manufacturers?
What is written in the IVDR?